FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
19393–19416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2020
Mega Plus MIS Spine System
K200981 · NKB
Bk Meditech, Co., Ltd.
Orthopedic · 119d
Cleared Aug 11, 2020
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1...
K201286 · NGT
Nurse Assist, LLC
General Hospital · 89d
Cleared Aug 11, 2020
CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo...
K201588 · GEH
Varian Medical Systems, Inc.
General & Plastic Surgery · 60d
Cleared Aug 11, 2020
LION Photocoagulator
K201623 · HQF
Norlase Aps
Ophthalmic · 57d
Cleared Aug 11, 2020
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K201722 · LNH
Hyperfine Research, Inc.
Radiology · 49d
Cleared Aug 11, 2020
ImagenSPECT 3.0
K201933 · KPS
Cardiovascular Imaging Technologies
Radiology · 29d
Cleared Aug 11, 2020
OMNI PLUS Surgical System
K201953 · MRH
Sight Sciences, Inc.
Ophthalmic · 28d
Cleared Aug 10, 2020
1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle,...
K192551 · MEG
Jiangsu Caina Medical Co.,Ltd
General Hospital · 328d
Cleared Aug 10, 2020
Masimo Rad-97 Pulse CO-Oximeter and Accessories
K193626 · MWI
Masimo Corporation
Anesthesiology · 228d
Cleared Aug 10, 2020
GS Medical AnyPlus PEEK Cage System
K200592 · ODP
GS Medical Co., Ltd.
Orthopedic · 157d
Cleared Aug 10, 2020
Precice® Bone Transport System
K201567 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 60d
Cleared Aug 10, 2020
Monterey AL Interbody System
K201585 · OVD
Stryker Corporation
Orthopedic · 60d
Cleared Aug 09, 2020
MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
K193006 · QCI
Tonica Elektronik A/S
Neurology · 286d
Cleared Aug 07, 2020
ProSeal™ Closed System drug Transfer Device (CSTD)
K192075 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 371d
Cleared Aug 07, 2020
Sterile High-pressure Angiographic Syringes for Single-use
K192657 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 317d
Cleared Aug 07, 2020
Fountain ValveTip Infusion Catheter
K193082 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 276d
Cleared Aug 07, 2020
MVP Aligner System
K193130 · NXC
Mvp Aligners, LLC
Dental · 269d
Cleared Aug 07, 2020
TaiChiA
K193207 · IYE
Our United Corporation
Radiology · 261d
Cleared Aug 07, 2020
MedSource CathMED IV Catheter
K193278 · FOZ
Medsource Labs
General Hospital · 254d
Cleared Aug 07, 2020
D-LUX+
K200809 · EBZ
DiaDent Group International
Dental · 133d
Cleared Aug 07, 2020
VIDAvision
K200990 · JAK
Vida Diagnostics, Inc.
Radiology · 114d
Cleared Aug 07, 2020
K2M Navigation Instruments
K201006 · OLO
K2m, Inc.
Orthopedic · 112d
Cleared Aug 07, 2020
CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain...
K201067 · HIS
Cupid Limited
Obstetrics & Gynecology · 107d
Cleared Aug 07, 2020
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
K201244 · KNW
Transmed7, LLC
Gastroenterology & Urology · 91d